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North American Prodromal Synucleinopathy Consortium Stage 2

About

Brief Summary

This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.

Study Type
Observational

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria for RBD Group

  • Polysomnogram-confirmed RBD by ICSD-3 criteria
  • Capable of providing informed consent at time of study enrollment
  • Age > 18 years

Exclusion Criteria for RBD Group

  • Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.
  • Narcolepsy-associated RBD
  • RBD secondary to any known cause except prodromal synucleinopathy.
  • Participation in a clinical trial, except by specific permission by the Executive Committee
  • In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol

Inclusion Criteria for Control Group

  • Ability to provide written consent
  • Age > 18 years
  • Must meet age, sex, and race matching criteria per the Data Management and Statistical core recommendations for the site
  • Must be willing to undergo all testing procedures, including neuroimaging and lumbar puncture.
  • Normal capacity to perform complex activities of daily living independently based on informant or physician report

Exclusion Criteria for Control Group

  • History of dream enactment behavior to suggest RBD
  • Parkinsonism, MSA, dementia, or mild cognitive impairment
  • Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning.
  • Contraindications to complete MRI.
  • Contraindications to lumbar puncture.
  • Participation in a clinical trial, except by specific permission by the Executive Committee
  • In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol

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Study Stats
Protocol No.
22-000732
Category
Brain/Neurological Diseases
Healthy Volunteers
Contact
Adreanne Rivera
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05826457
For detailed technical eligibility, visit ClinicalTrials.gov.